How are trials set up?

Clinical trials are designed by groups of medical and other specialists. The idea for a cancer trial usually comes from a thorough analysis of existing research, and a realisation that certain questions about treatment or symptom control need to be answered. The idea for the study is usually discussed with medical staff, nurses, patients, statistical experts and support staff, as well as representatives from drug companies, to draw up the best possible trial design. The design for the study is known as the protocol.

When the trial protocol is ready it is given to the relevant research ethics committee for approval. The research ethics committee is an independent group of people that includes doctors, nurses, medical staff, members of the public and sometimes lawyers. They decide whether the trial is ethical. In particular, they check that:

• the trial is looking at an important question in cancer care that cannot be answered using existing evidence from previous or current research
• the researchers are qualified to carry out the trial
• the protocol is suitable for the needs of the trial
• the probable benefits of a new treatment are likely to outweigh the side effects
• there is enough information for patients to decide whether they want to go into the trial
• the way in which people will be entered into the trial (recruited) is correct
• there will be compensation for people in the trial if something goes wrong, although it is unlikely that anything will go wrong
• the local health services have the resources to carry out the trial
• extra travel expenses will be offered to patients taking part
• the hospital research and development process has all the facilities to support the research.

When the ethics committee has given the go-ahead, the trial can begin.

The doctor or nurse who asks you to take part in a clinical trial may not be the person who designed and set up the study, especially if it is a very large study with patients in many different hospitals. But he or she will have been fully briefed about the study before agreeing to become involved and can give you all the information you need, or let you know where to get it. Your cancer specialist and GP are still the people in charge of your care, and are the people who can make the day-to-day decisions with you about your treatment.